Crimp and cut tool for sealing and unsealing guide wires and tubular instruments

ABSTRACT

An apparatus for modulating the pressure of a fluid such as a gas within the expandable portion of a guide wire catheter. The apparatus features a means for controllably gripping and releasing the open, proximal end of a tubular guide wire, means for introducing a fluid to a desired pressure and volume into the expandable portion of the tubular guide wire through the open end, and, while maintaining the pressure and volume of fluid in the tubular guide wire, a means for sealing the open end of said tubular guide wire to seal the fluid in the tubular guide wire. In a preferred embodiment, the apparatus also features a deflation tool for re-opening the sealed tubular guide wire and letting the fluid out. In a particularly preferred embodiment, the pressure and volume of fluid in the tubular guide wire is maintained by utilizing an apparatus to crimp the end of the tubular guide wire, effectively sealing the inside bore of the tubular guide wire. Here, a deflation tool might comprise a means of severing the crimp from the rest of the tubular guide wire, unsealing the bore of the tubular guide wire. Preferably, the crossing profile of the crimped tubular guide wire is no greater than what it was prior to crimping. Using this apparatus, the tubular guide wire can be re-sealed and re-opened as necessary.

RELATED APPLICATION CROSS REFERENCE

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/264,001, filed Oct. 3, 2002, which is acontinuation in part of U.S. patent application Ser. No. 10/227,996,filed Aug. 26, 2002, which are assigned to the same assignee as thisinvention and whose disclosures are fully incorporated by referenceherein.

BACKGROUND OF THE INVENTION

The invention generally relates to interventional or surgicalprocedures, specifically relating to interventional cardiology and otherintra-luminal procedures. The invention more particularly concerns avalve mechanism that allows modulation of pressure within a balloon orexpandable member attached to, or otherwise located thereon, of aguide-wire or other catheter-like instrument.

The use of a balloon attached to the end of a guide-wire is not new, seefor example U.S. Pat. No. 6,251,084 (Coelho), and U.S. Pat. No.4,790,813 (Kensey). In this arrangement, the guide-wire is actually asmall diameter tube, with the lumen therethrough serving to allow fluidto be injected, and with the fluid being an agent used to expand theballoon.

The balloon may serve various functions (e.g., locating and/or securingthe wire or associated device within the artery, securing a wire withina catheter, or blocking the distal flow of fluid and/or debris createdduring one or more of the procedures).

The balloon/guide-wire system may be used in various types oftherapeutic and/or diagnostic procedures (e.g., percutaneoustransluminal angioplasty, stent placement, the placement of ultrasonicor other diagnostic instruments, and the placement of thrombectomydevices, etc.). During the procedure several catheters or elongateinstruments (together “catheters”) may be used sequentially, with thesame guide-wire. Inserting instruments over, or alongside, a singleguide-wire saves procedural time, since only one guide-wire would needto be placed. This approach may also improve safety, and reduce chanceof infection, etc.

Inserting a plurality of catheters, whether singularly or concurrently,requires the catheter(s) to be placed over the proximal end of theguide-wire. Where the guide-wire is arranged with a balloon at or nearthe distal end, the catheter(s) would need to be passed over any valvelocated at the proximal end of the guide-wire.

Multiple catheters are commonly used when, for example, a physicianperforms an angiogram or other diagnostic procedure, and then decides toperform angioplasty or other therapeutic procedure or otherinterventional procedure. Most interventional procedures will requirethe placement of a guide wire for the subsequent delivery of theinterventional instruments, and more recently some guide wiresincorporate distal balloons to protect the distal tissues from debrisgenerated during those same procedures. Since treatment and diagnosticprocedures are becoming more commonplace, and the advancements in eachof these technologies have led to procedures using even more catheters.These catheters are continually getting smaller, which allows thephysician to reach tighter arteries and lumens within the body.

For distal protection to be effective the balloon must remain inflatedas catheters are exchanged over the guide wire. This necessitates asmall diameter valve, which some refer to as a low-profile valve.Self-sealing valves have previously been disclosed; see for example U.S.Pat. No. 3,477,438 (Allen, et al.), U.S. Pat. No. 3,495,594 (Swanson),U.S. Pat. No. 3,837,381 (Arroyo), and U.S. Pat. No. 4,752,287 (Kurtz, etal.). These valves are commonly made from elastic (Allen, et al., andKurtz, et al.) or resilient (Swanson) materials, and may requirepressure in the system to operate (Arroyo). The properties of thesevalve materials, together with their operational pressures, requirevarious of these valves to have large sealing areas. This does notfacilitate the design of smaller catheters. Additionally, the valveswould ideally operate over a wide range of pressures; including positiveand negative pressures.

Check valves have also been disclosed, see for example U.S. Pat. No.4,653,539 (Bell), however these are directional valves, and thereforewill not operate in both positive and negative pressure environments.Employing a vacuum in the system during navigation will facilitate thesecuring of the balloon to the guide-wire, that is, the balloon willstay folded or otherwise securely pressed against the side of the wire.This may allow the system to navigate tighter vessels or lumens.However, check valves, such as the one disclosed by Bell, do not meetthis bidirectional operation need. Additionally, this type of valve, aswell as the previously described self-sealing valves, require a syringeor special instrument to allow evacuation around the valve's sealingsurface. These syringes or needles must be in-place during the entireevacuation procedure, or the valve will cease the fluid flow. This opensthe systems up to situations where malfunctions or equipment breakagemay yield an inserted and expanded balloon, which may not readily becollapsed. A system is needed that will allow evacuation without theapplication of vacuum or other specialized components.

In addition to these stated concerns, the length of time required tocomplete the procedure is affected by these valves. This procedure timeis of concern because of escalating medical costs, as well as the stresson the patient. These valves must allow rapid infusion and evacuation ofballoon-filling fluids.

Yet another low profile catheter valve, designed to fit small diametercatheters to navigate small pathways within the body such as bloodvessels and ducts, is disclosed in U.S. Pat. No. 4,911,163 (Fina). Asyringe is attached to the proximal end of an elongated tubular conduit(e.g. catheter) and used to inflate a distal balloon. Once the balloonis inflated, the catheter is clamped at the proximal end, the syringe isremoved, and a plug is inserted into the lumen of the catheter, and thenthe clamp is removed. The plug is retracted and reinserted to adjust theballoon inflation volume as needed, using this same multi-stepprocedure. Needless to say, this type of valve is tedious to handle andthe need for a separate clamping system further complicates theprocedure and may potentially damage the catheter. Certainly theclamping pressures are very high, in order to totally collapse thecircular catheter bore such that fluid will not leak (until the plug isinserted). Reinflating the balloon would also cause integrity problemsif the catheter were reclamped at the same location.

Another such low profile catheter valve is disclosed in U.S. Pat. No.6,325,778 (Zadno-Azizi, et al.). This valve features a needle which isinserted coaxially with the guide-wire, wherein the needle is arrangedto cover a fluid outlet port. The rate of balloon inflation and collapseis limited by the rate at which gas leaves the fluid outlet port. Sincethe fluid outlet port is radially outward from the guide wire'slongitudinal axis, its size is geometrically constrained; that is, thelarger diameter of the port, the less strength the guide-wire has. Sincethe guide-wire must withstand significant bending and torsional stressduring the procedure, the port must be significantly less than theinside diameter of the guide-wire, thereby limiting the rate ofevacuation of the balloon-filling fluid.

This slow evacuation phenomenon may have been recognized by Coelho, asthe disclosure prescribes a vacuum to collapse the balloon. Indeed, thetortuous path in the orifice of the Coelho device, through which theballoon inflation fluid is evacuated, must be nearly as small as the onedisclosed by Zadno-Azizi. Here, the orifice must be considerably smallerthan the inside diameter of the guide-wire, because the path of fluidescape is through a self-sealing valve; and the valve must havesufficient integrity to cause a seal against itself, after an evacuationneedle is withdrawn.

A valve which may utilize the overall inside diameter (or bore) of theguide wire is disclosed in U.S. Pat. No. 5,807,330 (Teitelbaum). The twobasic concepts disclosed by Teitelbaum are a valve that is basically aninsert with threads, wherein the threads secure the valve in theproximal end of the guide-wire; and an insert with a press-fit geometry,that is pressed into the proximal end of the guide-wire. Both of theseconcepts suffer similar shortcomings.

The threaded insert requires extremely fine threads, which are expensiveand tedious to manufacture even before considering the limited wallthickness of the guide-wire available for threading (perhaps only a fewthousandths of an inch). Additionally, it is extremely difficult toalign small threaded parts of this sort, which leads to misalignment andcross-threading. This problem would be especially prevalent where thesame valve was actuated more than once during the same procedure—acommon occurrence.

The press-fit geometry requires parts of very tight tolerance, which arealso tedious and expensive to produce. Press-fit components are normallymanufactured for mechanical support, but press-fitting to cause a gasimpermeable seal is possible; however, the insert would require anextremely uniform surface, which mates exactly with the inside surfaceat the proximal end of the guide-wire. It is this guide-wire surfacewhich poses great manufacturing challenges.

Boring or machining the inside surface of the guide-wire is verychallenging because of the fine wall thickness—perhaps only a fewthousandths of an inch. Machining of this component may produceirregular wall thinning, since no tube inside and outside is trulyconcentric, which could lead to premature failure.

The aforementioned threaded and press-fit concepts disclosed byTeitelbaum both suffer manufacturing challenges as well as economicdisadvantages. Finally, they have features that may lead to prematurefailure, necessitating removal of the device, following by re-insertionof a new balloon/guide-wire assembly.

It is the intent of the embodiments of the present invention to overcomethese and other shortcomings of the prior art.

SUMMARY OF THE INVENTION

These and other objects of this invention are achieved by providing avalve mechanism for inflating and deflating a balloon or otherexpandable member on a guide-wire or catheter (e.g., at or near thedistal end of a guide-wire), such that while the balloon is inflated,the proximal end of the wire would have a low profile and would notinterfere with the use of other interventional devices usingover-the-wire technique or rapid exchange systems. The system basicallyconsists of detachable tools, one each for inflation and deflation ofthe balloon; additionally the inflation tool features in a preferredembodiment a gripping means, an inflating means, and a sealing means.

The inflation tool serves the functions of gripping and releasing theguide wire proximal end; providing a means of modulating the pressureinside the guide wire resulting in balloon or expandable memberinflation; and applying a deformable plug into the bore of the guidewire.

In use, the proximal end of the guide wire is inserted into a chamber ofthe inflation tool; pressure is introduced via the inflation meansthereby inflating the balloon or expandable member. The detachableinflation tool inserts a malleable plug in the proximal bore of theguide wire, thereby avoiding the need for costly machining andstringently tight tolerances of other devices, in order to maintainpressure within the guide wire upon the detaching the inflation tool.The sealing means prevents the escape of fluid (e.g., gas or liquid)from the guide wire for the duration of the procedure, or until releaseof pressure becomes necessary.

The deflation tool serves the function of relieving the pressure in theballoon or expandable member of the guide wire, by piercing the sealingmeans in the proximal bore of the guide wire, and upon tool removalallows the fluid contained therein to escape. The valve mechanism hereindescribed allows repeated inflation and deflation of the catheter orguide wire, by engaging the appropriate inflation or deflation tool.

An alternative embodiment may rely on any prior described or othermethodologies in the art for inflation; wherein the sealing may beaccomplished by crimping the guide wire or catheter, preferably in amanner such that the guide wire or catheter is crimped without creatingan increase in the effective diameter or crossing profile of the guidewire, thereby preventing the loss of pressure, and the deflation may beaccomplished by severing the crimped end of the guide wire or catheter.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional view of one design of tool for applying thesealing plug.

FIG. 2 is a perspective view of the sealing plug holding rod.

FIG. 3 is a perspective view of the cam sleeve.

FIG. 4 is a sectional view of the deflation needle tool prior toapplication.

FIG. 5 is a sectional view of the deflation needle tool duringapplication.

FIG. 6 is a schematic view of one design of tool for crimping andcutting a tubular guide wire.

FIG. 7 a is a sectional view of the crimping means and tubular guidewire.

FIG. 7 b is a sectional view of the crimped tubular guide wire.

FIG. 8 a is a sectional view of the cutting means and tubular guidewire.

FIG. 8 b is a sectional view of the cutting means and tubular guidewire.

FIG. 9 a is a cross sectional view of a guide wire crimped into a “C”shape.

FIG. 9 b is a cross sectional view of a guide wire crimped into a“cross” shape.

FIG. 10 is a perspective view of one design of tool for crimping andcutting incorporated into the tool for gripping and inflating.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Description of InflationTool

The preferred embodiment tool shown in FIGS. 1, 2 and 3, performsvarious functions, including but not limited to:

-   -   a) Gripping and releasing the guide wire proximal end;    -   b) Inflating the balloon on the distal end of the guide-wire, or        placed somewhere therealong; and    -   c) Applying a sealing member in the proximal bore of the guide        wire.

These various device embodiments comprise sealing means, gripping means,and inflation means; while a separate device features deflation means.It is recognized that the device arranged for deflation may be attachedto the device arranged for inflation (for convenience), although theymay not share any componentry other than structural or housing.Additionally, it is contemplated by this invention that an inflationdevice or “inflation tool” may not necessarily comprise each of agripping means, an inflation means, and a sealing means.

As a non-limiting example, it is recognized that the inflation means maybe a traditional syringe (where the inflation device was arranged toaccept same). It is also recognized that the gripping means may beuseful to perform other functions (e.g., gripping tubes at diagnosticand/or therapeutic equipment inlet ports, e.g., those found on bypassand dialysis machines.)

Referring now to FIGS. 1, 2, and 3, describing a preferred embodiment ofthe inflation tool, wherein like numbers indicate like components. Apreferred gripping means is disclosed, wherein a tubular guide wire 12,enters bore 37 in shaft 18 and passes through deformable member 19,through pierceable diaphragm 20, into cavity 21, and stops against theface 23A of rod 23. Shaft 18 is slidably mounted in bore 41 of housing28, and, driven proximally (relative to the guide-wire 12) by spring 16,thereby compressing deformable member 19 against the tapered bore 40 inhousing 28. Pierceable diaphragm 20 is an intact disc until pierced bythe entering tubular guide wire 12, the purpose of the diaphragm beingto capture a charge of fluid (e.g., CO₂ or saline) in cavities 45, 21,and channel 35, prior to the piercing by the guide-wire 12. Axialcompression of the deformable member 19 results in the tubular guidewire 12 being gripped as the deformable member is moved radially inwardby the taper 40. An alternative to the pierceable diaphragm forretaining the charge of fluid in the cavity 21 and 45 is to ship theassembly with a smooth mandrel gripped in the deformable member 19 (notshown).

In a preferred embodiment, the gripping means further features aninsertion-release means, wherein the shaft 18 can be driven distally(relative to the guide-wire 12) by movement of lever 15 which, pivotingon pin 14, moves the cone 13 attached to shaft 18. Thus movement of thelever 15 radially inward relieves the pressure on the deformable member19 and hence releases the guide wire 12 (the same feature may also beused in reverse, to assist the entry of the guide-wire into the device,as will be described later).

In a preferred embodiment the inflation tool features a sealing means,with the sealing means arranged to deliver a sealing member materialinto the guide-wire to effect a seal, as will be described later. Inthis embodiment, the sealing means is preferentially located at theproximal end of the device, wherein there exists a mounted rod 23 whichcan move axially and rotationally in bore 21A of housing 28. Rod 23 isdriven distally by spring 25 acting through flange 24 and is restrainedby arm 26 corning in contact with one of the grooves 42 or 43. An O-ringseal 29 seals rod 23 against bore 21A. A sealing member material 22 isinserted in an off center bore in rod 23. Surface 23A of rod 23 isstriated with grooves (not shown) to permit flow of fluid into the boreof tubular guide wire 12.

In a preferred embodiment the sealing member material is made from aplastically deformable or inelastic material, wherein such material maycomprise organic and/or inorganic material. It is recognized thatvarious materials may be suitable for this application, and the totalityof material properties (e.g., strength, ductility, thixotropy,toughness, malleability, hysteresis, adhesiveness and fluidpermeability, etc.) may reveal several good candidates.

In another embodiment, to be further discussed later, the sealing meanscomprises means for crimping a guide-wire or elongated tubularinstrument, and the deflation device comprises a means for cutting theguide wire distal to the crimped region. Within this embodiment, theguide wire inner diameter (I.D.) may further be coated with adeformable, malleable or other material arranged to facilitate sealingof the guide-wire after crimping. Alternatively, a pliable material(e.g. a filament) which does not contact the entire surface may beplaced in the I.D. and allowed to flow during the crimping process. Thesevering means may additionally feature a receptacle to contain thesevered, proximal end of the guide wire.

In a preferred embodiment the inflation tool features inflation means.At the lower portion of FIG. 1 is shown a preferred embodiment of theinflation means, comprising an inflation syringe 44, wherein the syringecontains a barrel 30 arranged to be attached to body 28 using adhesiveor a threaded joint (not shown). The charge of fluid is pre-charged intocavities 45, 21 and 35. A piston 31 attached to a plunger 32 drivesfluid (gas or liquid) from chamber 45 via channel 35 into chamber 21 andthence into tubular guide wire 12. Another preferred embodimentadditionally features a latch 33 fastened to barrel 30, wherein thelatch 33 engages flange 34 after the plunger has been moved inward todeliver the fluid. The latch serves to prevent the piston and plungerfrom being driven back by the pressure trapped in cavity 21 (etc.) andballoon 11.

Description of Inflation Tool Use

A preferred embodiment inflation tool includes the gripping, inflation,and sealing means in combination, and allows the operator to hold theassembly 1 in one hand and with the thumb and fore-finger to squeeze thelever 15 toward the body 28 thus moving shaft 18 distally and relievingpressure on the deformable member 19. The guide wire 12 is then insertedinto shaft 18, centralized by the tapered inlet 38, passed through thedeformable member 19, to pierce the diaphragm 20 and come to restagainst rod 23 at surface 23A. Chamfers at 39 and 36 further aid incentralizing the guide wire. Surface 23A of rod 23 is striated with finegrooves (not shown) to permit flow of fluid into the bore of tubularguide wire 12. When the guide wire has bottomed on surface 23A, the userreleases the lever 15, whereupon the shaft 18 is propelled to proximallyand deformable member 19 is placed in compression. In turn this action,through taper 40, causes the deformable member 19 to grip the guide wire12 securely.

In a preferred embodiment, the position of the guide wire may beconfirmed visually by viewing the location via the lens 46 built in to aclear plastic housing 28. Alternatively, if the housing is made from anopaque material the viewing lens 46 can be inserted in a tunnel as aseparate component (not shown).

In yet another embodiment, the correct position of the guide wire 12 canalternatively be ascertained by observing the location of a contrastingband of color 60, formed on the guide wire 12, relative to the entrance61 of shaft 18.

Now returning to the preferred combination embodiment, the plunger 32and attached piston 31 are then driven inward to propel the fluid incavity 45 through channel 35 into cavity 21 and thence through the boreof guide wire 12 into the balloon 11. In the case where gas is used toinflate the balloon, the plunger 32 may be driven to the bottom of thebore and allowed to return to a position controlled by flange 34 andlatch 33. This over-compression of the gas permits the initial pressureto be high to overcome the balloon resistance but drops the pressure asthe balloon reaches full size, thus reducing the tendency tooverpressure the vessel (not shown) in which the balloon is residing.

With the balloon 11 inflated in the vessel, the arm 26 is rotated 180degrees in this example (but any other angle would work with slots 42 &43 placed differently) so that rod 23 revolves to place the sealingmaterial 22 to a position opposing the guide wire 12. Then spring 25urges rod 23 distally and drives the sealing material 22 into the openend of tubular guide wire 10 thus trapping the fluid in the guide wireand balloon. A plug 50 of sealing material 22, is driven into the boreof the tubular guide wire 12, as shown in FIG. 4.

At this point the lever 15 is again pressed inward radially and theguide wire is removed from the device, and the wire is ready for therest of the interventional procedure, which might involve the passage ofangioplasty balloons, stent balloons, diagnostic ultrasound, or otherprocedure requiring a balloon protected or anchored guide wire with theballoon inflated.

Description of Deflation Tool

Referring to FIGS. 4 and 5, a preferred embodiment of the deflation tool56 is basically constructed from four elements, a handle 51, a tube 54,a spring 52, and a needle 53. The handle has a bore 57 of about 0.016inch diameter, a little larger than the outside diameter of the guidewire 12 which is typically 0.015 inch, and has a lead in taper 55 toallow the operator to easily locate the bore 57.

The proximal end (relative to the user's hand while utilizing the tool)of the needle 53 is held centrally in the bore 57 by tube 54. Tube 54,together with the needle 53, and the handle 51 can be assembled togetherby any convenient means, including but not limited to welding, using anadhesive, or a crimping operation. The needle is approximately 0.005inch in diameter in this embodiment, and is supported by the springcoils 52 to prevent the needle from being bent during use and to alignthe distal end (relative to the user's hand while utilizing tool) of theneedle on the centerline of the bore 57. The length of the plug 50 ofsealing member material 22 (see FIG. 1) in the proximal end of the guidewire 12 is preferably about 0.030 inch long axially, although otherdimensions may be more suitable depending on the composition of thesealing material and the pressure at which the balloon requires. Theguide wire outside diameter 59 is typically 0.015 inch and the bore 58can typically range from 0.011 inch to 0.005 inch. The needle needs tobe sufficiently large to provide a bore through the plug 50 that it willallow the balloon to be deflated rapidly, but not so large that the plug50 is smeared along the bore 58 too far to require a very long needle.It has been found that a 0.005 inch diameter needle permits deflationtimes that are acceptable (less than 30 seconds), utilizing a 0.007 inchdiameter guide wire bore. Clearly these dimensions are examples only andcould be adjusted to accommodate guide wires or catheters of differentdiameters.

The deflation tool embodiment described can be used multiple times, butit is unlikely that the operator will ever need to inflate and deflatethe balloon more than 5 times in a procedure. The needle 53 is thereforepreferably required to penetrate several times the length of the plug 50into the guide wire bore 58 for this to be achieved.

In an alternative embodiment, the balloon may be deflated by using asevering means (e.g., a cutting tool) to unseal the guide wire bore, asshown in FIG. 7, to be discussed later.

Description of Deflation Tool Use

The operator inserts the proximal end of the guide wire 12 into the leadtaper 55 of the deflation tool 56 compressing the spring 52 to the fullycompressed condition. The plug 50 is pierced as shown in FIG. 5, andsmears into an elongated tubular shape 62 concentric to the bore 57. Theballoon 11 (see FIG. 1) then deflates due to its inherent elasticrecovery, and/or vacuum can be applied to the tubular guide wire 12 bysyringe or other means (neither shown) to accelerate the deflation time.The tool is then removed and is available for any subsequent use.

Thus since the invention disclosed herein may be embodied in otherspecific forms without departing from the spirit or generalcharacteristics thereof, some of which forms have been indicated, theembodiments described herein are to be considered in all respectsillustrative and not restrictive, by applying current or futureknowledge. The scope of the invention is to be indicated by the appendedclaims, rather than by the foregoing description, and all changes whichcome within the meaning and range of equivalency of the claims areintended to be embraced therein.

Description of Crimping Tool

In an alternative embodiment, as shown in FIG. 6, the sealing isaccomplished by means of a crimping tool 70, to maintain the inflationof a balloon or expandable member on or about the distal end of thecatheter. A preferred embodiment of the crimping tool, may incorporate acrimping mechanism (not shown) contained within the barrel 72, andaround or next to the central bore 74, of the tool 70, and may provide ahand grip 77, lever 78, and spring 79 in order to actuate the crimpingmechanism. Referring to FIGS. 7 a and 7 b, the crimping mechanism mayincorporate a plurality of dies 88, that when actuated compress thetubular guide wire 12, effectively sealing the tubular guide wire. Thetool may also provide a mechanism for controlling the location of thecrimp 90, by providing a stop 89 (e.g., a flat surface), located withinthe crimping tool bore 74 (as shown in FIG. 6), in order to allowconsistent placement of the crimped section 90 from the end of the guidewire 12 or catheter. In the embodiment of the invention shown in FIG. 6the tool passes over the wire without a stop, as the positioning of thecrimp is not critical and may be performed without exact positioning ofthe crimp. In an alternative embodiment (not shown), the barrel 72 maybe split parallel to the axis in order for the guide wire 12 to beinserted sideways into the crimping tool.

Inserting a plurality of catheters, whether singularly or concurrently,requires the catheter(s) to be placed over the proximal end of theguide-wire. Where the guide-wire is arranged with a balloon at or nearthe distal end, the catheter(s) would need to be passed over any valvelocated at the proximal end of the guide-wire. To facilitate this, theinvention may provide a crimped section of guide wire or catheter whichis not of a larger outside diameter than the outside of the balance ofthe guide wire, or at least not of a larger outside diameter than theregions of the guide wire immediately adjacent the crimp. This may beaccomplished, for example, by tailoring the dies, such that the crimpedsection of the guide wire is caused to collapse in on itself. In oneembodiment the dies may compress the guide wire 12′ into a “C” shape, asshown in FIG. 9 a, where the inside surface 58′ is collapsed onto itselfby deforming part of the guide wire 59′. Alternatively, the dies may bepointed, and used, for example, in greater numbers, see FIG. 9 b. A setof four pointed dies may be used to create a “cross” shaped crimp in theguide 12″.

As previously described, one beneficial aspect of the invention involvesusing the crimping tool to create a crimped section in the guide wire orcatheter, where the action of crimping does not result in an increase inthe effective outside diameter, or crossing profile of that crimpedsection, relative to the effective outside diameter or crossing profileon the originally uncrimped section. It is also recognized that presentinvention may be utilized with a guide wire or catheter having anon-uniform construction or tapered design, for example, where a distalportion is of a narrower diameter than a proximal portion. Such a tapermay allow for increased flexibility, wherein the distal portion isbetter able to navigate further into portions of the body, especiallynarrow and more tortuous vasculature. It is recognized that a crimpcreated as described above, where the crimp is not larger than thepreviously uncrimped portion, may in fact be of greater dimension thananother portion of the guidewire, specifically the narrowed distalportion of the guide wire or catheter. In this embodiment, the presentinvention creates the crimp in a manner that ensures that the act ofcreating the crimp does not result in a net increase in effectiveoutside diameter or crossing profile of the crimped portion. By creatinga crimp in this manner, there is no need for a reduced diameter sectionof the guide wire, which prior art has previously described as beingutilized to serve as a dedicated crimpable section of the guide wire,wherein the reduced diameter is necessary to allow for an increase inoutside effective diameter as a result of the application of prior artcrimping devices.

In a preferred embodiment, the three-part device, previously described,includes a crimping (i.e. sealing means, gripping means, inflationmeans) means (and in one embodiment, a cutting means), e.g., see FIG. 1.Alternatively, sealing means and inflation means may be used inconjunction with each other, whether in the same tool or not (notshown).

As can be seen in FIG. 10, in another embodiment, the crimping tool 70may be the sealing means incorporated into the tool of FIG. 1additionally comprising the gripping means, and inflation means. Theorientation of the handles, is illustrated as a non-limiting example,the orientation may be different for various applications of the tool.

Description of Crimping Tool Use

After the balloon is inflated by the inflation means of FIG. 1, or byanother method (e.g., a syringe) known in the art, the sealing isaccomplished by utilizing the crimping tool 70 of FIG. 6, to crimp theguide wire 12 such that the bore 65 is sealed. To facilitate aneffective sealing of the crimped guide wire 12 (as shown in FIG. 7 a),one embodiment of the invention contemplates coating the inner surface58 of the guide wire 12 with a deformable, malleable material or otherpliable material not contacting the entire I.D. (not shown) that mayform a sealing gasket upon crimping by the crimping tool.

In use, the guide wire 12, is gripped within the central bore 74 (asshown in FIG. 6) of the barrel 72 of the crimping tool 70, and iscentered between the faces of the plurality of dies 88, as shown in FIG.7 a. Referring to FIG. 6, the user actuates the dies 88, by squeezingthe lever 78 together with hand grip 77, compressing spring 79, andactuating the dies 88 shown in FIG. 7 a, to pinch closed the bore 65 ofthe guide wire 12, forming a seal. Upon release of the pressure on thehand grip 77 and lever 78, the spring 79 urges open the dies 88,releasing the compression upon the guide wire 12 or catheter, therebyrendering the guide wire bore 65 sealed, and releasing the catheter fromthe crimping tool.

Description of Cutting Tool

A preferred cutting tool embodiment provides a means of deflating theballoon or expandable member on or about the end of the catheter orguide wire, by severing the aforementioned crimped end of the guide wireor catheter, releasing the pressure contained therein. It is within thecontemplation of the invention that the cutting tool may be containedwithin the crimping tool 70 of FIG. 6 (hereinafter also referred to asthe cutting tool 70 interchangeably), or alternatively the cutting toolmay be a separate tool entirely (not shown). In one embodiment, shown inFIG. 6 (wherein the cutting tool is contained within the crimping tool70), the cutting tool 70 may comprise a lever 78, hand grip 77 andspring 79, actuating a cutting mechanism (not shown). In one embodiment,the cutting mechanism drives a plurality of cutting discs 82 as shown inFIG. 8 a. A plurality of centralizing rollers 84, may also be driven bythe cutting mechanism, located about a central bore 74, as shown in FIG.6, of the cutting tool 70. In an alternative embodiment, the cuttingmechanism may consist of multiple shear blades, or other methodssuitable for cutting tubular instruments known to those skilled in theart. Within the cutting tool 70, there may also be a container 75 toentrap the severed end of the guide wire upon application of the cuttingtool.

Description of Cutting Tool Use

The cutting tool, whether a separate instrument (not shown) or containedwithin the crimping tool 70 of FIG. 6, may be used to reopen the crimpedend of the guide wire 12 and allowing deflation of a balloon orexpandable member, or whenever there is a need to sever an end of thecatheter or guide wire 12. In use, the catheter 12 is located within thebore 74 of the cutting tool 70. Whereupon the hand grip 77 and the lever78 are squeezed together, compressing the spring 79, and actuating thecutting mechanism, resulting in a circumferential rotation about theguide wire 12, by both the centralizing rollers 84, as shown in FIG. 8b, and the cutting discs 82, while concurrently urging the centralizingrollers 84 and cutting discs 82 radially towards and against the guidewire 12. The revolving centralizing rollers 84 serve to maintain theposition of the guide wire 12 in the cutting tool 70, while the cuttingdiscs 82 serve to sever the guide wire 12. After completely severing theend of the guide wire 12, the squeezing pressure applied to the cuttingtool 70 of FIG. 6 via the handgrip 77, lever 78 and spring 79 isreleased, thereupon also releasing the guide wire 12 from thecentralizing rollers 84 and cutting discs 82.

Thus since the invention disclosed herein may be embodied in otherspecific forms without departing from the spirit or generalcharacteristics thereof, some of which forms have been indicated, theembodiments described herein are to be considered in all respectsillustrative and not restrictive. The scope of the invention is to beindicated by the appended claims, rather than by the foregoingdescription, and all changes that come within the meaning and range ofequivalency of the claims are intended to be embraced therein.

1. An apparatus for maintaining the pressure of a fluid within anexpandable member on a tubular guide wire, the apparatus comprising:means for controllably gripping a tubular guide wire, the tubular guidewire comprising an inside surface that defines a bore; and a crimpingmeans to provide a crimping action by compressing said tubular guidewire, thereby creating a crimp, while maintaining said expandable memberinflated to a desired extent, thereupon sealing said bore of saidtubular guide wire, said crimping means designed to impart said crimpsuch that the crimped section of tubular guide wire does not include alarger outside effective diameter than the outer diameter of the balanceof the guide wire.
 2. The apparatus of claim 1, further comprising ameans for re-opening a proximal end of said tubular guide wire.
 3. Incombination with the apparatus of claim 1, a tubular guide wire and adeformable material to facilitate sealing, wherein said tubular guidewire comprises an inside surface that defines a bore, with saiddeformable material contacting at least a portion of said insidesurface.
 4. The apparatus of claim 1, wherein said crimping meanscomprises a plurality of dies mounted in said apparatus, said diesarranged to move radially to apply a compressive force to said tubularguide wire, thereby deforming said guide wire and sealing said bore ofsaid guide wire.
 5. The apparatus of claim 1, further comprising a stoparranged within the apparatus, such that an open, proximal end of saidtubular guide wire is urged against said stop to consistently locatesaid crimping action, and consistently create a crimp in said tubularguide wire.
 6. The apparatus of claim 2, wherein said means forre-opening said proximal end of said tubular guide wire comprises acutting tool to sever said crimp from said tubular guide wire.
 7. Theapparatus of claim 6, wherein said cutting tool further comprises aplurality of cutting discs, said cutting discs being capable of movingcircumferentially about said tubular guide wire as well as radially tosaid tubular guide wire.
 8. The apparatus of claim 6, wherein saidcutting tool further comprises a mechanism for stabilizing the tubularguide wire, such that said cutting tool is correctly aligned.
 9. Theapparatus of claim 8, wherein said mechanism for stabilizing the guidewire comprises a plurality of centralizing rollers, arrangedcircumferentially around about said tubular guide wire, to stabilizesaid tubular guide wire as said cutting tool is employed.
 10. Theapparatus of claim 6, wherein said cutting tool is arranged to entrapsaid severed crimp.
 11. The apparatus of claim 1, wherein said crimpingmeans comprises a plurality of dies.
 12. The apparatus of claim 11,wherein said dies are tailored in such a way as to deform part of theguide wire.
 13. The apparatus of claim 11, wherein said dies compresssaid guide wire into a cross-section having a “C” shape.
 14. Theapparatus of claim 11, wherein said dies compress said guide wire into across-section having a “cross” shape.
 15. An apparatus for modulatingthe pressure of a fluid within an expandable member on a guide wire ortubular instrument, the apparatus comprising an inflation tool whichcomprises: means for controllably gripping an open proximal end of aguide wire or tubular instrument; means for introducing a fluid intosaid expandable member on said guide wire or tubular instrument throughsaid open end, thereby inflating said expandable member of said guidewire or tubular instrument to a desired extent; and means for sealingsaid open proximal end of said guide wire or tubular instrument to sealsaid fluid in said guide wire or tubular instrument, while maintainingsaid expandable member inflated to a desired extent, the apparatusfurther comprising a means for re-opening said proximal end of saidguide wire or tubular instrument, said re-opening means comprising acutting tool arranged to sever said guide wire or tubular instrumentdistally of said sealed proximal end, said cuffing tool furthercomprising a mechanism for stabilizing the guide wire or tubularinstrument, whereupon the guide wire or tubular instrument is correctlyaligned, wherein said mechanism comprises a plurality of centralizingrollers arranged to rotate circumferentially about said tubular guidewire.
 16. A valve mechanism for modulating pressure in a balloon orexpandable member on or about a catheter or guide wire, the valvemechanism comprising; a) an inflation tool, the inflation toolcomprising an inflating means, the inflating means comprising a chargeof fluid, and a means for modulating the pressure of the charge of fluidin said catheter or guide wire; and a crimping means; the crimping meanscomprising a tool suitable for sealing and maintaining pressure in thecatheter or guide wire, by applying radial pressure by a plurality ofdies upon said catheter or guide wire, thereby creating a crimp andsealing said catheter or guide wire such that a crossing profile of saidcrimped section is no larger than said crossing profile prior to saidcrimping; and b) a deflation tool, the deflation tool comprising cuttingmeans arranged to sever the crimp of the catheter or guide wire from theremainder of the catheter or guide wire, thereby unsealing said catheteror guide wire.
 17. The valve mechanism of claim 16, wherein saidcatheter or guide wire comprises a deformable material to facilitatesealing, and said catheter or guide wire comprises an inside surfacethat defines a bore, with said deformable material contacting at least aportion of said inside surface.
 18. The apparatus of claim 16, whereinsaid dies are tailored in such a way as to deform part of the catheteror guide wire.
 19. The apparatus of claim 16, wherein said dies compresssaid catheter or guide wire into a cross-section having a “C” shape. 20.The apparatus of claim 16, wherein said dies compress said catheter orguide wire into a cross-section having a “cross” shape.
 21. Theapparatus of claim 16, wherein said dies compress said catheter or guidewire in such a way as to cause said catheter or guide wire to collapseon itself.
 22. The apparatus of claim 16, wherein the creation of saidcrimp does not result in an increase in the outside effective diameterof the catheter or guide wire.
 23. The apparatus of claim 16, whereinsaid catheter or guide wire is tapered.
 24. The apparatus of claim 16,wherein said catheter or guide wire is tapered at a distal end.